# Class II recall Z-0170-2027: Medline Industries, LP

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0170-2027 |
| Recalling firm | Medline Industries, LP |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Medline surgical convenience kits labeled as:    1) OPEN HEART CDS, Medline product number/SKU CDS840094R;   2) OPEN HEART CDS, Medline product number/SKU CDS840171AG;   3) MHC AV FISTULA, Medline product number/SKU DYNJ903705K;   4) PERIPHERAL VASC MAJR-LF, Medline product number/SKU CDS840379O;   5) MINOR VASCULAR PACK-LF, Medline product number/SKU DYNJ0349727D;   6) SJHC VASCULAR PK-LF, Medline product number/SKU DYNJ19906L;   7) CABG PACK-LF, Medline product number/SKU DYNJ0824648K;   8)  PERIPHERAL VASC MNR-LF, Medline product number/SKU DYNJ22721N;   9) HEART A PACK, Medline product num |
| Reason | Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. |
| Quantity | 193374 kits |
| Distribution | US Nationwide distribution. |
| Recall initiated | 2026-09-02 |
| Reported | 2026-10-21 |
| Firm location | Northfield, IL, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0170-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.